High-Resolution CT for Heart

NCT07169201 | Recruiting DMC

• 1 other identifier: HiTe-CT
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective observational study aims to evaluate a high-resolution coronary CT platform (uCT SiriuX Pro) for non-invasive assessment of coronary plaque biomechanics and functional physiology in high-risk patients. The system enables CT-derived radial wall strain (CT-RWS), a novel biomarker reflecting plaque vulnerability, with potential correlation to invasive OCT findings and clinical outcomes. The study will assess the diagnostic performance and prognostic value of CT-RWS, along with a new CT-based index of systolic flow perfusion (CT-SFPR) for evaluating the hemodynamic relevance of myocardial bridging, compared to nuclear perfusion imaging. Additionally, left ventricular ejection fraction derived from dynamic CTA (CT-EF) will be compared with echocardiography to evaluate its feasibility and accuracy. This is the first study to comprehensively validate CT-RWS, CT-SFPR, and CT-EF using a fully non-invasive, high-temporal-resolution CT platform.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• correlation between CT-RWS and Angiography-derived RWS/OCT-detected vulnerable plaque features

  We will measure the RWS derived from coronary CT angiography (CT-RWS). After patients undergo coronary angiography and OCT examinations, we will also measure the angiography-derived RWS, both expressed as percentages. Correlation analyses will be performed to investigate the association between CT-RWS and angiography-derived RWS. In addition, OCT plaque characteristics, including thin-cap fibroatheroma, lipidic plaque burden, and lipid-to-cap ratio, will be assessed. Correlation analyses will be conducted to explore the relationships between CT-RWS and these OCT-derived plaque characteristics.

  Perioperative/Periprocedural

Secondary Outcomes (1)

• CT perfsusion and myocardial bridging

  Baseline

Other Outcomes (1)

• prognostic value of CT-RWS

  from enrollment to 3-year follow up

Study Arms (3)

Cohort for CT-RWS

This cohort includes patients with suspected or known coronary artery disease undergoing coronary CTA using a high-temporal-resolution CT scanner (uCT SiriuX Pro). Patients must have at least one lesion with moderate-to-severe stenosis (≥50%) on CTA. All participants will subsequently undergo invasive coronary angiography and OCT. The study aims to assess the correlation between CT-derived radial wall strain (CT-RWS) and OCT-defined plaque vulnerability features, including thin-cap fibroatheroma (TCFA), lipidic plaque burden, and lipid-to-cap ratio (LCR). CT-RWS will be derived from coronary CTA using a dedicated algorithm. OCT will serve as the invasive reference for plaque characterization. No investigational drug or device will be used. Lesion-level comparisons will evaluate whether CT-RWS can serve as a non-invasive surrogate of plaque biomechanics.

Diagnostic Test: Angiography based RWS and OCT based plaque characteristcis

Cohort for myocardial bridging

This cohort includes patients with myocardial bridging (MB) identified on coronary CTA using a high-temporal-resolution CT scanner (uCT SiriuX Pro). Patients must have symptoms suggestive of ischemia and elevated systolic flow perfusion ratio (CT-SFPR), a novel CT-based index designed to quantify dynamic systolic compression of the bridged coronary segment. Eligible patients will undergo invasive coronary angiography with physiological assessment using resting full-cycle ratio (RFR) to evaluate the functional significance of MB. The primary objective is to assess the correlation between CT-SFPR and invasively measured RFR. CT-SFPR will be calculated from multiphase coronary CTA using a dedicated post-processing algorithm. No investigational drugs or devices are involved. The cohort aims to validate CT-SFPR as a non-invasive marker for MB-related ischemia.

Cohort for prognosis

This cohort includes patients with suspected or known coronary artery disease who undergo coronary CTA using a high-temporal-resolution CT scanner (uCT SiriuX Pro). CT-derived radial wall strain (CT-RWS) will be calculated for coronary lesions using a dedicated post-processing algorithm. All patients will be followed prospectively for up to 2 years to monitor the occurrence of major adverse cardiovascular events (MACE), including cardiac death, non-fatal myocardial infarction, and target vessel revascularization. The primary objective is to assess the prognostic value of CT-RWS for predicting future cardiovascular events. CT-RWS will be analyzed both as a continuous variable and based on predefined thresholds to identify high-risk plaque biomechanics. No investigational interventions will be applied. This cohort aims to validate CT-RWS as a non-invasive imaging biomarker for long-term risk stratification.

Interventions

Angiography based RWS and OCT based plaque characteristcis DIAGNOSTIC_TEST

Angiography based RWS and OCT based plaque characteristcis

Cohort for CT-RWS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

In this study, we consecutively enrolled patients who were either suspected or diagnosed with coronary artery disease (CAD) in the outpatient setting, as well as those with diabetes presenting with atypical symptoms. Patients were eligible for inclusion if they were willing to undergo coronary CT angiography (CTA) followed by invasive coronary angiography. Major exclusion criteria included contrast agent allergy, impaired renal function, a history of coronary artery bypass grafting, and any other condition deemed unsuitable for CTA or invasive coronary angiography.

You may qualify if:

• Adults ≥18 years with suspected or known CAD or with type 2 diabetes

You may not qualify if:

• those can not undergo CTA and angiography

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2025
• First Posted: September 11, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2030
• Last Updated: March 17, 2026

Record last verified: 2025-08

Locations

CN (1)